FDA Grants SKYRIZI Approval to Children With Plaque Psoriasis and PsA

The FDA has expanded the indication for SKYRIZI® (risankizumab-rzaa) to include children aged 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, according to an announcement from AbbVie.

The approval also adds a new 55 mg pre-filled syringe designed for weight-based dosing in children weighing less than 40 kg, to the existing 150 mg pre-filled syringe and pen remain available for patients weighing 40 kg or more. According to AbbVie, SKYRIZI is now the first and only IL-23 inhibitor approved in the United States for pediatric patients aged 6 years and older weighing less than 40 kg with plaque psoriasis or PsA.

The approval was supported by data from the OptIMMize clinical trial program, evaluating risankizumab in children and adolescents with plaque psoriasis. The pediatric PsA indication was supported by the OptIMMize program alongside pharmacokinetic modeling and extrapolation from adult PsA studies.

"At Week 16 in part 2 of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment," said Amy S. Paller, MD, chair of dermatology and professor of pediatrics at Northwestern University Feinberg School of Medicine and study investigator in the OptIMMize program, said in a press release. "These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children living with plaque psoriasis or psoriatic arthritis." 

Source

AbbVie press release. June 30, 2026.